Registration Dossier

Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable report which meets basic scientific principles
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1972
Report Date:
1972

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Internal BASF method
GLP compliance:
no
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Hydroxycitronellal (HCA); 3.7-Dimethyl-7-hydroxyoctanol-1
- Physical state: liquid
- Purity: approx. 99%

Test animals

Species:
mouse
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: mean 25.5 g (male), 22.3 g (female)

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
CMC (carboxymethyl cellulose)
Details on exposure:
- Concentration: 4 - 30%
Doses:
200, 250, 320, 400, 500, 640, 800 ccm/kg bw
No. of animals per sex per dose:
10
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: prior to study begin
- Necropsy of survivors performed: yes

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
504 mL/kg bw
95% CL:
441 - 576
Sex:
male
Dose descriptor:
LD50
Effect level:
517 mL/kg bw
95% CL:
407 - 656
Sex:
female
Dose descriptor:
LD50
Effect level:
486 mL/kg bw
95% CL:
413 - 572
Mortality:
800 ccm/kg bw: 4/20 within 24 h; 6/20 within 48 h; 16/20 within 7 days
640 ccm/kg bw: 1/20 within 24 h; 5/20 within 48 h; 12/20 within 7 days; 13/20 within 14 days
500 ccm/kg bw: 2/20 within 24 h; 5/20 within 48 h; 9/20 within 7 days
400 ccm/kg bw: 3/20 within 48 h; 7/20 within 7 days
320 ccm/kg bw: 3/20 within 24 h; 4/20 within 48 h; 6/20 within 7 days; 7/20 within 14 days
250 ccm/kg bw: 1/20 within 24 h
Clinical signs:
accelerated respiration, atonia, apathy, crusted eyes; 7 - 10 days after application without abnormal findings
Gross pathology:
splenomegaly, general passive hyperemia, intestinal atony; liver: clay-colored to gray

Applicant's summary and conclusion